Device for staunching uterus bleeding

ABSTRACT

A device for staunching uterine bleeding comprising an expandable balloon and a tubular handle connected therewith for the insertion of the balloon into the uterine cavity, which can be connected to a fluid source for pressurizing the balloon to effecting and maintain the expansion thereof. The balloon is dimensioned to fill the uterine cavity at expansion and to exert pressure against the bounding wall thereof over substantially the total surface of the wall. The device further includes a pump and control unit and a hose connected to one end thereof with the handle at the other end thereof with a connection element for connecting to a fluid source. The hose can be detachable mounted to the pump and control unit in operative co-operation therewith and forms together with the balloon and the handle a separate unit for one-way use.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a device for staunching uterine bleedingcomprising an expandable balloon and a tubular handle connectedtherewith for the insertion of the balloon into the uterine cavity, ahose for connecting the balloon to a fluid source, and means forsupplying fluid under pressure to the balloon to effect and maintain theexpansion thereof, the balloon being dimensioned to fill the uterinecavity at expansion and to exert pressure against the bounding wallthereof over substantially the total surface of said wall.

2. Description of the Related Art

EP-A1-0 141 589 discloses a device of this kind which comprises asemi-rigid flexible rubber tube and an expandable balloon of elasticfoldable material, which is connected to the tube and can be expanded bypressurized fluid, gas or liquid, being supplied to the balloon throughthe tube. In the prior art device the tube forms a handle for theinsertion of the balloon into the uterine cavity.

BRIEF SUMMARY OF THE INVENTION

The purpose of,the invention is to provide a device for staunchinguterine bleeding, which can be used easily and allows the treatment tobe performed at great safety in hygienic and operative respect in orderto staunch uterine bleeding also under severe conditions, and whichallows accurate adjustment to varying probe measures as well as controlof the pressure in the balloon at contraction of uterus while anhemostatic effect being maintained over the total bounding surface ofthe uterine cavity.

This is achieved by providing a device for staunching uterine bleedingwhich is of the kind referred to above and according to the inventionhas obtained the characterizing features of claim 1.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order to explain the invention in more detail an illustrativeembodiment of the device will be described reference being made to theaccompanying drawings in which

FIG. 1 is a plan view of a balloon and hose unit forming part of thedevice,

FIG. 2 is a fragmentary side view of a handle in the balloon and hoseunit,

FIG. 3 is a cross-sectional view of the handle along line III--III inFIG. 2,

FIG. 4 is a plan view of a pump and control unit forming part of thedevice for supply of liquid to the balloon,

FIG. 5 is a fragmentary plan view of a modified embodiment of theballoon and hose unit of the device, and

FIG. 6 is a view corresponding to FIG. 5 with the balloon furtherexpanded.

DETAILED DESCRIPTION OF THE INVENTION

The balloon and hose unit disclosed in the drawings FIGS. 1-3 comprisesa tubular handle 10 of translucent or transparent soft plastic oranother comparable material, which is easy to grip and forms flat upperand lower sides and curved side surfaces as will be seen from FIG. 3. Atone end the handle forms a socket 11 having a outwardly flaring endportion 12. A hose 13 which consists preferably of silicone rubber(medical quality) or another comparable material and for reasons whichwill appear below preferably is translucent or transparent is pushedthrough the handle and the socket and projects therefrom at the flaringportion. The hose is glued to the handle. A scale 14 is provided on theupper side of the handle, and on this side there is also indicated acircular field 15 with legend PRESS.

A tube 16 which preferably consists of plastic or rubber of medicalquality such as polyethylene (LE6601-PH) and is relatively stiff butnevertheless can be bent and can maintain temporarily the bent shape ispartly inserted into hose 13 through the end thereof which protrudesfrom socket 11 and can be displaced axially in relation to the hose andthus in relation to the handle. The tube can have a colour whichcontrasts with the colour of the handle, and the position of the innerend 16A of the tube, which as a consequence thereof can be easily seenthrough the handle can be read at scale 14. In FIG. 1 the end issubstantially at 107 on the scale. By pressing the thumb againstpressure field 15 on the handle pressure can be exerted against tube 13by deformation of the handle and the hose therein and thus the tube canbe arrested in a desired displaced position in relation to the hose andthe handle by frictional engagement between the hose and the tube. Tothe end of hose 13 projecting from the handle there is attached at 18 aballoon 19 which is attached also to a plug 20 which is attached to andcloses the outer end of tube 16. Thus, tube 16 is completely enclosed bythe balloon, and apertures 17 open in the interior of the balloon.Preferably, the balloon consists of thin silicone rubber (medicalquality) or another comparable elastically extendible and/or foldablematerial such as polyurethane.

Hose 13 via a pressure cell 22 having a finger grip 22A is connectedwith an end piece 23 having a connection spike 24 i.e. a tube integralwith the end piece, which has a point at the free end thereof formed bythe tube being obliquely cut. The unit formed by the end piece and theconnection spike preferably is made of ABS or another comparablematerial and is available on the market under the term plastic cannula.

The balloon and hose unit now described according to the invention shallbe operatively combined with the pump and control unit shown in FIG. 4,and it shall be made as a one-way product i.e. it shall be delivered ina sterile package and it shall be scrapped after a single use.

The pump and control unit shown in FIG. 4 can be battery operated and isintended to be placed on a support (a bed or a table) but it can also beprovided with means for suspending the same on a drop stand. Said unitcomprises a control box 25 wherein there is mounted an electric drivemotor for a rotor 26 of a peristaltic pump said rotor being mounted onthe upper side of the control box. A loop 13A formed by hose 13 isapplied around rotor 26, as shown, and is kept engaged with half thecircumference of the rotor by a stationary guide 27 in order tooperatively co-operate with the rotor and to form together with therotor a peristaltic pump. In the upper side of the control box adepression 28 is provided which fits the pressure cell 22 which islocated in the depression having at the bottom thereof a pressure sensor(not shown) for sensing the pressure in the pressure cell. In thecontrol box there are means for measuring volume with an associatedvolume indicator 29, and for measuring pressure with an associatedpressure gauge 30 indicator and gauge being located on the upper side ofthe control box where there is also a knob 31 for setting a nominalvalue of the pressure and a time indicator 32. Moreover, there is on thecontrol box a button 33 for switching the pump and control unit on andoff as well as indicator lamps 34 and 35.

Control box 25 shall also contain the electronic system required forcontrolling functions in connection with the use of the device, whichshall be performed automatically without any action from the operator.At the state of the art in the field of electronics such an electronicsystem can be proposed by the average man skilled in the art and,therefore, it will not be described in more detail here.

When the device described is to be used in order to provide a hemostaticeffect in the uterine cavity when this is bleeding cannula 23, 24 shouldbe connected to a fluid source which can comprise a plastic bag withphysiological salt solution; the cannula is easily put into theconnection socket on the bag while penetrating the membrane closing saidsocket. Hose 13 and pressure cell 22 should be placed in the pump andcontrol unit in the manner disclosed in FIG. 4. With balloon 19 in thedeflated condition the operator grips handle 10 and presses againstpressure field 15 so that tube 16 will be arrested in a protrudingposition. The tube with the enclosing balloon 19 is now inserted intothe uterine cavity via vagina and cervix, the tube forming directionalmeans at the insertion which can be further facilitated by thepossibility of permanently bending the tube. When plug 20 engages thedistal wall of uterus, which the operator feels or can investigate bymeans of X-ray if plug 20 and possibly also tube 16 contains radioopaque material, the tube is released by the operator relieving thepressure against pressure field 15. The handle can now be displaced inrelation to tube 16 which will stand stationary due to the engagement ofthe plug against the wall of the uterine cavity, until the flangedportion 12 engages cervix. In this position the distance from the end ofplug 20 to the flanged portion 12 represents the so called probemeasure, and scale 14 on handle 10 indicates this measure which can bered against the scale at end 16A of the tube, said end being visiblethrough the handle and the hose.

The pump and control unit is switched on by means of button 13, and thensignal lamp 34 will be lit up. A nominal value of the pressure to bemaintained in balloon 19 during the hemostatic treatment of the uterinecavity is set by means of knob 31. Rotor 26 starts rotating clockwise asindicated by an arrow in FIG. 4, and liquid will be sucked from theliquid source and will be supplied under pressure to the interior ofballoon 19 via hose 13, pressure cell 22, handle 10, tube 16, andapertures 17. The flow direction of the liquid is indicated by an arrowin FIG. 4. The pressure of the liquid supplied is sensed by the pressuresensor via pressure cell 22. During the supply of liquid the balloon 19will be expanded under elastic extension or by smoothing away existingfolds, respectively, until the balloon completely fills the uterinecavity and engages the wall thereof. As liquid is being supplied thepressure against the wall will be increased, and this pressure isidentical with the pressure sensed by the pressure sensor and indicatedby pressure gauge 30. When the nominal value set has been reached thepump will be stopped so that the supply of liquid will cease. Theattainment of the nominal value of the pressure is indicated by signallamp 35 being lit up. Volume meter 29 indicates the amount of liquidthat has been supplied to the balloon, and this meter should be of thetype which maintains the indication of the largest volume reached evenif the volume then should decrease, the meter at the same timeindicating the actual liquid volume.

The balloon is kept pressurized as long is deemed necessary for thehemostatic treatment of uterus. During the treatment uterus may contractwhich normally happens after a birth but also may be initiated bymedical treatment, and such contraction means of course that thepressure will increase. By automatic control in the electronic systemthe pump will then be started again but is now allowed to operate in theopposite direction for draining liquid from the balloon until the setnominal value of the pressure has again been reached. The volume meternow indicates the volume of liquid present in the balloon for the timebeing the indication of the original volume of liquid at the same timebeing maintained. During the treatment tube 16 can be freely moved inhandle 10, and at the contraction of uterus the tube will be pressedinto the handle and will indicate on scale 14 the reduced probe measureexisting after contraction, which is important information for theoperator at the treatment. The period over which the treatment is goingon is indicated on time indicator 32, and when the necessary treatmentperiod has been reached knob 31 will be set on the nominal value zero orin a reverse position the balloon then being emptied completely by thepump operating in counter-clockwise direction and pumping the liquidback to the liquid source. The balloon is withdrawn from uterus, and theballoon and hose unit is separated from the pump and control unit and isscrapped.

In the embodiment disclosed there is provided a peristaltic pump but itis within the scope of the invention to provide a pump of another kindto which the balloon and hose unit is connected.

The pump can also comprise a pressure cuff which encircles the bagcontaining physiological salt solution and is provided with a manometerand a degassing valve. When liquid is supplied to the balloon thepressure cuff is pressurized until the liquid is under the desiredpressure, and when the pressure of the fluid is increased due tocontraction of uterus air is discharged from the pressure cuff until thedesired pressure has been restored.

In FIGS. 5 and 6 there is shown a modified embodiment of the balloon. Inthis case tube 16 is attached to hose 13 and plug 20 is detachablyconnected with the tube by being inserted into the tube at a pin 36,FIG. 5. The pin has such fit in the tube that the plug at apredetermined pressure in the balloon will be pressed out of the tube,FIG. 6, so that the balloon can completely freely adapt itself to theshape of uterus. Instead of being provided with a pin the plug may forma socket fitting over the outside of tube 16. The pin can also be solong, without covering apertures 17, that the plug is always guided inthe tube.

We claim:
 1. Device for staunching uterine bleeding comprising anexpandable balloon and a tubular handle connected therewith for theinsertion of the balloon into the uterine cavity, a hose for connectingthe balloon to a fluid source, and means for supplying fluid underpressure to the balloon to effect and maintain the expansion thereof,the balloon being dimensioned to fill the uterine cavity at expansionand to exert pressure against the wall defining said cavity oversubstantially the total surface of said wall, wherein the devicecomprises also a control unit including said means for supplying fluidunder pressure, and a pressure gauge, the hose at one end thereof ispassed through the handle and connected with the balloon, and at theother end thereof has a connector for connection to the fluid source,and said hose together with the balloon the handle and the connectorforms a separate unit for one-way use.
 2. Device as in claim 1, whereinsaid means for supplying fluid under pressure comprises a motor drivenrotor which together with said hose forms a peristaltic pump.
 3. Deviceas in claim 2, wherein said control unit comprises means for controllingthe rotation of the rotor in dependence of indicated pressure.
 4. Deviceas in claim 1, wherein said means for supplying fluid under pressurecomprises a pressure cuff with air pump, the pressure cuff encircling aflexible liquid container to be connected to the hose.
 5. Device as inclaim 1, wherein a proximal end of the balloon is connected with thehandle while a distal end thereof can be displaced in relation to thehandle.
 6. Device as in claim 5, wherein a distal end of the balloon isconnected with an outer closed end of a tube projecting from the handle,said tube being connected to the hose and being perforated tocommunicate with the interior of the balloon.
 7. Device as in claim 6,wherein one end of the tube is guided for axial displacement in thehandle.
 8. Device as in claim 7, wherein the tube can be arrested in thehandle.
 9. Device as in claim 8, wherein the handle is of an elasticallydeformable material for transferring manual pressure against the handleto the tube (16) for arresting the tube by frictional engagement. 10.Device as in any of claims 7-9, wherein the handle is translucent ortransparent for determination of the displaced position of the tube byocular observation of the position of a tube end positioned in thehandle, in relation to a scale provided on the handle.
 11. Device as inclaim 10, wherein the tube at least at said tube end has a colorcontrasting with that of the handle.
 12. Device as in claim 6, whereinthe tube at said outer end thereof is closed by means of a plug which isdetachably provided on or in the tube end.
 13. Device as in claim 12,wherein the plug is displaceably guided in the tube.
 14. Device as inclaim 6, wherein the tube can be plastically bent at least partly. 15.Device as in claim 1, wherein the hose and balloon unit comprise apressure cell in the hose which can be detachably mounted on saidcontrol unit for operative cooperation with a pressure sensor providedtherein.
 16. Device as in claim 1, wherein said control unit comprisesmeans (29, 30) for indicating the amount of fluid supplied to theballoon (19).
 17. Device as in claim 1, wherein the balloon consists ofan elastic material to expand under elastic extension thereof. 18.Device as in claim 1, wherein the balloon is folded to expand while thefolds are being smoothed away completely or partly.
 19. Device forstaunching uterine bleeding comprising an expandable balloon; a tubularhandle for insertion of the balloon into the uterine cavity, a proximalend of the balloon being connected with tubular handle; a hose connectedat one end thereof with the tubular handle; a tube displaceably receivedby the tubular handle and projecting therefrom, a distal end of theballoon being connected with an outer closed end of said tube extendinginto the balloon and communicating with the interior thereof through aperforation of the tube; a connector at the outer end of the hose; acontrol unit including means for supplying fluid under pressure, and apressure gauge for measuring the pressure of the fluid supplied, saidconnector being connected to said control unit for delivery of fluidunder controlled pressure to the balloon to effect and maintain theexpansion thereof, the balloon being dimensioned to fill the uterinecavity at expansion and to exert pressure against the wall defining saidcavity over substantially the total surface of said wall, said hosetogether with the balloon, the handle, the tube, and the connectorforming a separate unit for one-way use.
 20. Device as in claim 19,wherein the tube can be arrested in the handle.
 21. Device as in claim20, wherein the handle is of an elastically deformable material fortransferring manual pressure against the handle to the tube forarresting the tube by frictional engagement.
 22. Device as in claim 21,wherein the handle is translucent or transparent for determination ofthe displaced position of the tube by ocular observation of the positionof a tube end positioned in the handle, in relation to a scale providedon the handle.